A TISSUE OXYGEN MONITOR

组织氧监测仪

• 批准号: 6183857
• 负责人: WARREN C CLAY
• 金额: $ 37.49万
• 依托单位: NORFOLK ENGINEERING
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6183857
• 关键词: biomedical equipment development; electrochemistry; electrodes; laboratory rabbit; miniature biomedical equipment; monitoring device; oximetry; perfusion; plastic surgery; postoperative state; transplantation

The research plan is for the continued development and evaluation of a miniature, mechanically rugged, simple, inexpensive, minimally invasive, electrochemical oxygen sensor. It is intended for insertion in flap or free muscle transplants after reconstructive surgery and will monitor oxygen for up to five days. An outer sheath controls the operating environment of the sensor and a membrane excludes large molecules that would contaminate the electrodes. The measurement cycle is designed to avoid interference from smaller species. Dimensions and processes expected to affect the accuracy or stability of the device will be systematically evaluated and final process and material specifications and tolerances established. Special tooling and equipment will be designed and built to improve reproducibility and reduce fabrication costs. Screening methods will be developed to reject defective components and to provide feedback on processes for improved yields. Devices will be tested extensively in the laboratory for accuracy, stability, and response time. Evaluation protocols will include sterilization and storage. Short term performance will be evaluated in rabbit tissue flaps with active manipulation of blood supply. Long term stability will be evaluated in rabbits with flaps or free tissue transfers. All animal studies will include a second sensor in intact or less disturbed tissue. Indicated oxygen level will be compared with venous oxygen levels, clinical indications of poor perfusion, and degree of transfer necrosis. Tissue from the long term animals will examined for adverse foreign body reactions to the device. PROPOSED COMMERCIAL APPLICATIONS: The device will be used to permit direct monitoring of tissue oxygenation after grafting during reconstructive surgery and provide early warning of clotting of blood vessels. It addresses limitations of existing devices and provides clinically relevant data not presently available. It is expected to capture a significant portion of a market estimated at $8,000,000 in the US.

该研究计划是为了继续开发和评估微型、机械坚固、简单、廉价、微创、电化学氧传感器。它用于在重建手术后插入皮瓣或游离肌肉移植中，并可监测氧气长达五天。外护套控制传感器的操作环境，膜排除会污染电极的大分子。测量周期的设计是为了避免较小物种的干扰。将系统地评估预计影响设备精度或稳定性的尺寸和工艺，并确定最终工艺和材料规格和公差。将设计和制造特殊的工具和设备，以提高可重复性并降低制造成本。将开发筛选方法来拒绝有缺陷的组件，并提供有关提高产量的工艺反馈。设备将在实验室进行广泛的准确性、稳定性和响应时间测试。评估方案将包括灭菌和储存。将通过主动控制血液供应来评估兔组织皮瓣的短期性能。将在带有皮瓣或游离组织移植的兔子中评估长期稳定性。所有动物研究都将包括在完整或较少受到干扰的组织中的第二个传感器。将指示氧水平与静脉氧水平、灌注不良的临床指征以及转移坏死程度进行比较。将检查长期动物的组织是否对装置产生不良异物反应。拟议的商业应用：该设备将用于在重建手术期间直接监测移植后的组织氧合，并提供血管凝血的早期预警。它解决了现有设备的局限性，并提供目前无法获得的临床相关数据。预计它将占据美国价值 8,000,000 美元的市场的很大一部分。